Cross-sectional HIV incidence surveillance, using assays that distinguish 'recent' from 'nonrecent' infections, has been hampered by inadequate performance and characterization of incidence assays. In this study, the Consortium for the Evaluation and Performance of HIV Incidence Assays presents results of the first independent evaluation of five incidence assays (BED, Limiting Antigen Avidity, Less-sensitive Vitros, Vitros Avidity and BioRad Avidity). A large repository of diverse specimens from HIV-positive patients was established, multiple assays were run on 2500 selected specimens, and data were analyzed to estimate assay characteristics relevant for incidence surveillance. The mean duration of recent infection (MDRI, average time 'recent' while infected for less than some time cut-off T) was estimated from longitudinal data on seroconverters by regression. The false-recent rate (FRR, probability of testing 'recent' when infected for longer than T) was explored by measuring the proportions of 'recent' results in various subsets of patients. Assays continue to fail to attain the simultaneously large MDRI and small FRR demanded by existing performance guidelines. All assays produce high FRRs amongst virally suppressed patients (>40%), including elite controllers and treated patients. Results from this first independent evaluation provide valuable information about the current performance of assays, and suggest the need for further optimization. Variation of 'recent'/'nonrecent' thresholds and the use of multiple antibody-maturation assays, as well as other biomarkers, can now be explored, using the rich data generated by the Consortium for the Evaluation and Performance of HIV Incidence Assays. Consistently high FRRs amongst those virally suppressed suggest that viral load will be a particularly valuable supplementary marker.

Objective: Post-marketing surveillance was conducted to monitor the performance of the OraQuick Advance rapid HIV-1/2 antibody test (OraQuick) on whole blood and oral fluid. Design: Surveillance of routinely collected data on clients tested with OraQuick in 368 testing sites affiliated with 17 state and city health departments between 11 August 2004 and 30 June 2005. Methods: For whole blood and oral fluid, we report the median (range) health department OraQuick specificity and positive predictive value (PPV), and the number of clients with discordant results (e.g. who had a reactive rapid test not confirmed positive by Western blot or indirect immunofluorescence). At one site with lower than expected oral-fluid specificity, we evaluated whether device expiration, manufacturing lot, operator practices, or device-storage or testing-area temperatures were associated with false-positive tests. Results: During the surveillance period, 135 724 whole blood and 26 066 oral fluid rapid tests were conducted. The median health department whole blood OraQuick specificity was 99.98% (range: 99.73–100%) and PPV was 99.24% (range: 66.67–100%); the median oral fluid specificity was 99.89% (range: 99.44–100%) and PPV was 90.00% (range: 50.00–100%). A total of 124 discordant results were reported from 68 (0.05%) whole blood and 56 (0.22%) oral fluid rapid tests. The oral fluid specificity at the site with excess oral fluid false-positive tests was 98.7% (95% confidence interval: 98.18–99.11%). The increase in false-positive tests at that site was not associated with any specific device characteristic, operator procedure or temperature condition. Conclusion: The specificity of OraQuick performed on whole blood and oral fluid during post-marketing surveillance was compatible with the manufacturer's claim within the package insert. However, one site experienced lower than expected oral fluid specificity. Sites that observe that the specificity of OraQuick is lower than the range indicated in the package insert should notify the manufacturer and evaluate quality assurance procedures.

Objective: Assays for classifying HIV infections as ‘recent’ or ‘nonrecent’ for incidence surveillance fail to simultaneously achieve large mean durations of ‘recent’ infection (MDRIs) and low ‘false-recent’ rates (FRRs), particularly in virally suppressed persons. The potential for optimizing recent infection testing algorithms (RITAs), by introducing viral load criteria and tuning thresholds used to dichotomize quantitative measures, is explored. Design: The Consortium for the Evaluation and Performance of HIV Incidence Assays characterized over 2000 possible RITAs constructed from seven assays (Limiting Antigen, BED, Less-sensitive Vitros, Vitros Avidity, BioRad Avidity, Architect Avidity, and Geenius) applied to 2500 diverse specimens. Methods: MDRIs were estimated using regression, and FRRs as observed ‘recent’ proportions, in various specimen sets. Context-specific FRRs were estimated for hypothetical scenarios. FRRs were made directly comparable by constructing RITAs with the same MDRI through the tuning of thresholds. RITA utility was summarized by the precision of incidence estimation. Results: All assays produce high FRRs among treated patients and elite controllers (10–80%). Viral load testing reduces FRRs, but diminishes MDRIs. Context-specific FRRs vary substantially by scenario – BioRad Avidity and Limiting Antigen provided the lowest FRRs and highest incidence precision in scenarios considered. Conclusion: The introduction of a low viral load threshold provides crucial improvements in RITAs. However, it does not eliminate nonzero FRRs, and MDRIs must be consistently estimated. The tuning of thresholds is essential for comparing and optimizing the use of assays. The translation of directly measured FRRs into context-specific FRRs critically affects their magnitudes and our understanding of the utility of assays.

Community-based participatory research (CBPR) increasingly is being used in both developed and developing countries to study and address community-identified issues through a collaborative and empowering action-oriented process. In 2003–2005, a study was undertaken to document the impacts of CBPR on healthy public policy in the US. From an initial review of 80 partnership efforts, 10 were selected as best capturing the range and diversity of projects meeting the study criteria, and were the subject of in-depth case study analysis. This article presents and analyzes one of these cases, a collaboration between researchers at the Indiana University School of Nursing and the Healthy Cities Committee of New Castle, IN, USA. With its action component still underway a decade after the formal study's completion, the partnership was selected to enable an examination of sustainable change through CBPR. Beginning with a participatory door-to-door health survey of 1000 households using a non-probability quota sampling strategy, the project involved community members in many stages of the research process. A smoking rate of twice the national average was among the study findings that helped to galvanize the community into action. A variety of health promoting environmental and ‘small p policy’ changes were undertaken ranging from a bill restricting indoor smoking in public places to an initiative to develop a system of trails throughout the county to promote physical fitness and decreased reliance on automobiles. This article examines the evolution of the original CBPR partnership, its research methods and findings, and the environmental changes it sought to promote healthier lifestyles. Success factors, barriers and sustainability benchmarks are discussed. The case study offers an example of the potential of CBPR for helping to lay the groundwork for long-term sustainable change in support of healthier communities.

Current laboratory and point-of-care tests for HIV detect different analytes and use different sample types. Some have fast turnaround times (<1 hour). We investigated how HIV test choice could impact case finding by testing programs. We analyzed 21,234 consecutive HIV tests with venous blood obtained by San Francisco HIV testing programs from 2003 to 2008. For a subset, oral fluid (n = 6446) or fingerstick blood (n = 8127) samples were also obtained for rapid testing. In all cases, HIV status was determined using an HIV antibody-plus-RNA test algorithm. We assessed how the screening antibody tests performed individually versus the gold standard of the full algorithm. We then evaluated the potential ability of other tests (including new tests) to detect more cases, by re-testing all specimens that had negative/discrepant antibody results on initial screening. The antibody-RNA algorithm identified 58 acute and 703 established HIV infection cases. 1^st-generation (Vironostika) and 3^rd-generation (Genetic Systems) immunoassays had 92 and 96 percent sensitivity, respectively. The Oraquick rapid test had clinical sensitivity of only 86 percent on oral fluid samples, but 92 percent on finger-stick blood. Newer 4^th-generation, antigen-antibody combo rapid immunoassay (ARCHITECT) detected HIV in 87 percent of all the acute cases that had been missed by one of the previous screening assays. A point-of-care 4^th generation antigen-antibody combo rapid test (Determine) detected about 54 percent of such acute cases. Our study suggests that some rapid antibody blood tests will give similar case detection to laboratory antibody tests, but that oral fluid testing greatly reduces ability to detect HIV. New 4^th-generation combo tests can detect the majority of acute infections detectable by HIV RNA but with rapid results. Using these tests as a primary screening assay in high-risk HIV testing programs could reduce or eliminate the need for HIV RNA testing.